Job DescriptionWork location: Trumbull, CT or Livingston, NJ (on-site)
Scope: The Sr. Global CAPA Engineer serves as a subject matter expert for the Global Corrective and Preventive Action (CAPA) Program, providing technical leadership, facilitation, and guidance to ensure effective investigation, root cause analysis, corrective action implementation, and effectiveness verification across CooperSurgical.
This role partners with Quality, Regulatory Affairs, Operations, Manufacturing, R&D, Supply Chain, and other functional teams to support the timely execution of CAPAs, strengthen problem-solving capabilities, and drive continuous improvement across the organization.
Job Summary:The Sr. Global CAPA Engineer is responsible for supporting the execution and effectiveness of CooperSurgical's Global CAPA Program. This role provides expert guidance to CAPA owners on investigation techniques, root cause analysis, risk evaluation, corrective action development, effectiveness verification, and documentation requirements.
The Sr. Global CAPA Engineer facilitates complex and high-risk CAPAs, performs quality reviews of CAPA records, analyzes CAPA trends, and identifies opportunities to improve quality system performance. Working closely with cross-functional stakeholders, this role helps ensure CAPAs are executed consistently, effectively, and in compliance with applicable regulatory requirements and company procedures.
Responsibilities• Provide technical guidance and support to CAPA owners throughout all phases of the CAPA process.
• Facilitate complex, high-risk, and cross-functional CAPAs to ensure timely progression and successful completion.
• Review CAPA records for completeness, scientific rigor, and compliance with established procedures.
• Support investigation activities, root cause analysis, corrective action planning, and effectiveness verification.
• Conduct quality reviews of CAPA documentation to ensure records are complete, accurate, and inspection ready.
• Identify and escalate risks that may impact CAPA quality, timelines, or regulatory compliance.
• Support remediation activities related to audit observations, inspection findings, quality events, and systemic issues.
• Ensure CAPA activities comply with internal procedures and applicable regulatory requirements.
• Monitor CAPA performance metrics, aging, and effectiveness trends.
• Analyze data to identify recurring issues, systemic trends, and opportunities for improvement.
• Support development of management reporting, dashboards, and CAPA performance reviews.
• Recommend process improvements that enhance CAPA effectiveness and quality system maturity.
• Coach CAPA owners and cross-functional teams on root cause analysis, investigation methodologies, corrective action planning, and effectiveness verification.
• Deliver CAPA-related training and onboarding sessions.
• Perform other duties as assigned.
Travel: This position may require 10-20% domestic and/or international travel.
QualificationsKnowledge, Skills and Abilities:- Knowledge of 21 CFR 820, ISO 13485, EU MDR regulatory requirements.
- Experience managing projects at a Global Level in a regulated environment.
- Six Sigma Green Belt or above
- Strong decision-making skills, ability to influence and collaborate with cross-functional teams
- Strong technical writing skills
- Ability to provide critical review and feedback on quality records
- Ability to read and interpret technical and regulatory documentation.
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
- Effective written and verbal communication skills (English).
- Ability to work independently and collaboratively across global cross-functional teams in a regulated environment.
- Ability to work in a fast-paced setting with shifting priorities while maintaining attention to detail and compliance standards.
Work Environment:- Primarily office-based with regular use of computer systems and virtual collaboration tools
Experience:- 5+ years of experience in medical device, pharmaceutical, biologics, or other regulated industries.
- 3+ years of direct CAPA, quality engineering, quality systems, or compliance experience.
- Demonstrated experience leading complex investigations and root cause analyses.
- Working knowledge of FDA QMSR, ISO 13485, MDSAP, and EU MDR requirements.
Education:- Bachelor's degree in biomedical engineering or related technical discipline.
- ASQ Certified Quality Engineer (CQE) preferred.
- Project Management Certifications preferred.
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Our Benefits:As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $100,000.00 - $125,000.00. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.
